越南保健食品登记法规问题集
Email：han4ww@evershinecpa.com
或
越南永辉BPO有限公司
联络人: 林幸穗 Anny Lin 协理
手机：+886-937-606-272
skype: annylin8008
wechat: annylin8008
电话：+886-2-2717-0515 分机:110
HLF-VN-10
请问越南对于保健食品的归类方式为何？它的正式名称为何？不同归类管理强度有何差异?它的政府管辖机构为何？网页？
What are the categories of health food in Vietnam? What is its official name? What is the intensity of management of different categories? What is the governmental authority of health food? Website?
Evershine RD：
在越南，保健食品的主管机构是卫生部（MoH）辖下的越南食品管理局（VFA），负责收集和批准进口保健食品之登记，以及负责发布相关法规。
保健品也称为食品补充剂、膳食补充剂，用作日常饮食的补充，为提高使用者的健康和免疫力，可能含有以下一种或多种物质：
1. 维生素、矿物质、氨基酸、脂肪酸、酶、益生菌等生物活性物质。
2. 从动物、矿物、植物中以提取物、分离物、浓缩物或代谢物形式提取之物质。
3. 上述物质的组合来源。
保健品可以是软胶囊、丸剂、片剂、颗粒剂、粉剂、液体和其他剂型，或为更小的剂量。
In Vietnam, the competent authority for health food is the Vietnam Food Administration (VFA) under the Ministry of Health (MoH), which is responsible for collecting and approving the registration of imported health food and issuing relevant regulations.
Health products, also known as food supplements and dietary supplements, are used as a supplement to the daily diet and may contain one or more of the following substances to improve the health and immunity of the user:
1. Bioactive substances such as vitamins, minerals, amino acids, fatty acids, enzymes, and probiotics.
2. Substances extracted in the form of extracts, isolates, concentrates or metabolites from animals, minerals and plants.
3. Combination sources of the above substances.
Nutraceuticals can be in the form of softgels, pills, tablets, granules, powders, liquids and other dosage forms, or in smaller doses.
HLF-VN-20
外国公司要到越南销售保健食品，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？
假如要，其必要条件是什麽？所需文件及申请程序为何？网页？
If a foreign company wants to sell health food in Vietnam, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration?
If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
无须申请营业特许证。
No business license is required.
【参考连结】
https://reurl.cc/qNr40g
HLF-VN-25
假如需要办理，请问越南有专业服务公司可以协助办理保健食品公司营业许可证？
Evershine RD：
无须申请营业特许证。
No business license is required.
HLF-VN-30
外国公司要到越南销售保健食品，可以指派越南公司担任营业代理人销售吗? 担任营业代理人，其必要条件是什麽？所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？
If a foreign company wants to sell health food in Vietnam, can it assign an Vietnam company to act as a business agent? What are the requests for acting as a business agent? What are the required documents and application procedures? What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
可以。当地企业/个人身分皆可提出产品许可申请。
保健品是食品类别，因此在越南生产和销售保健品的生产商、贸易商必须向食品管理局（VFA）提交产品自我公告登记。
申请表内容
1.组织或个人名称、地址、电话、传真、电子邮件、业务代码
2.食品安全合格证书编号、发证日期/地点
3.产品信息：名称、成分、保质期、包装规格及包装材料
4.产品製造商名称、地址
5.产品声明
当发现不安全产品时，生产、销售保健品的个人或企业应召回不安全产品并向越南食品管理局（VFA）提交报告，生产、销售者应当处理该产品，并承担全部召回和处理费用。
在某些紧急情况下，国家主管部门可以直接召回和处置不安全食品，并要求生产、销售者报销召回和处置费用。
此外，根据消费者权益保护法，一旦发现有缺陷的产品，製造商/贸易商必须立即採取一切必要措施，停止在市场上供应此类产品。这包括召回有缺陷的产品，并在至少连续 5 期日报或连续 5 天在产品流通地区的广播或电视上发布有关缺陷产品的信息。
此外，如果有缺陷的产品对消费者的生命或健康造成严重损害，贸易商/製造商必须向消费者支付赔偿。
An application can be made as a local business/person.
Health products are food, so manufacturers and traders who produce and sell health products in Vietnam must submit product self-announcement registration to the Food Administration (VFA).
Contents of the application form
1. Organization or personal name, address, telephone, fax, email, business code
2. Food safety certificate number, date/place of certificate issuance
3. Product information: name, ingredients, expiration date, packaging specifications and packaging materials
4. The name and address of the manufacturer of the product
5. Product Declaration
When unsafe products are found, individuals or enterprises that produce and sell health supplements should recall the unsafe products and submit a report to the Vietnam Food Administration (VFA).
In some emergency situations, the national competent authority can directly recall and dispose of unsafe food, and require the manufacturer and seller to reimburse the recall and disposal costs. Furthermore, in accordance with consumer protection law, as soon as a defective product is discovered, the manufacturer/trader must immediately take all necessary measures to stop supplying such product on the market. This includes recalling defective products and publishing information about defective products in at least 5 consecutive daily newspapers or 5 consecutive days on radio or television in the area in which the product is circulated. In addition, the trader/manufacturer must pay compensation to the consumer if the defective product causes serious damage to the consumer’s life or health.
【参考连结】
HLF-VN-35
假如需要办理指派越南公司担任营业代理人，请问越南有专业服务公司可以协助？
HLF-VN-40
外国公司销售到越南保健食品本身，进口前需要办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？保健食品包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？
Do foreign companies need to apply for an approval before importing health food sold to Vietnam? If yes, which authority is in charge? What documents are required? What is the application process? Do health food packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
需要，可以以外国企业/个人、当地企业/个人身分提出申请。
保健品是食品类别，因此在越南生产和销售保健品的生产商、贸易商必须向食品管理局（VFA）提交产品自我公告登记。
流程
1. 申请人通过网路、邮寄或纸本向卫生部提交进口保健食品产品申报註册申请。
网页： https://vfa.gov.vn/dich-vu-cong.html（VFA）
2. 自收到充分文件之日起 21 个工作日内，卫生部将核实申请并签发註册产品申报证书。文件核验时限自收到网上公共服务系统（如果是网上提交申请）或卫生部盖章（如果是邮寄或直接提交申请）规定的日期开始计算。
3. 如果需要补充，卫生部应当书面说明并说明法律依据，要求申请人补充申请1次。自收到补充申请之日起7个工作日内予以核实并作出书面答复。申请人自提出书面请求之日起90个工作日内未补正申请的，申请将失效。
4. 产品名称、产地或成分发生变更的，应另行申请。如有其他变更，申请人应书面通知卫生部，之后有权继续生产或销售该产品。
5. 卫生部应在其网站上公佈并在食品安全数据库中更新其产品声明已註册的供应商的名称和产品。
6. 申请人应按照收费法律规定缴纳文件验证费用。
7. 法规产品自我公告的有效期为 3 年。
8. 只有登记者才可以将产品进口，不同的进口商想要进口相同的产品，必须另外提出註册。
登记文件包括：
1. 申请表。
2. 原产国或出口国主管当局签发的自由销售证明/出口证明/健康证明，内容为确保用户安全或在生产国/出口国市场上自由销售（领事认证）。
3. 指定实验室或符合 ISO17025 的实验室出具的食品安全数据表原件或经核证无误的副本(自我声明前 12 个月内出具的)，数据表必须符合国际法规（如果没有卫生部的相关法规，则由供应商依据卫生部规定的安全指标为标准）
4. 证明产品或成分用途的科学证据（组织或个人认证的原件或副本），当使用科学证据证明产品的成分用于产品用途时，产品的每日剂量必须至少大于或等于手册中所述成分使用量的 15%。
5. 进口产品为保健食品需具备食品安全和良好生产规范（GMP）合格证明或同等证明。
．卫生部列入与越南签署GMP检查互认协议的国家名单中的製造商。
．ICH（国际人用药品技术要求协调委员会）国家或澳大利亚的製造商，已通过美国（美国食品和药物管理局 – USFDA）、欧盟国家（欧洲）的 SRA 之一的 GMP 合规性检查药品管理局 – EMA）、澳大利亚（治疗用品管理局 – TGA）、日本（药品和医疗器械管理局 – PMDA）或加拿大（加拿大卫生部）GMP的证明。
．对于未颁布GMP的国家，需以书面形式确认製造商符合保健品或草药产品和传统医药产品製造的要求和条件，或在主管当局的官方网站上公佈符合性。
6. 定期监测计划。
7. 产品标籤样本。原产国的原始标籤和越南语的标籤。
8. 成品样品。
9. 商业登记证或投资证(经单位或个人认证的食品经营许可证或食品进口商法人资格证明)
10.符合HACCP 或同等标准的证书。
11.註册文件必须用越南语书写；其他语言的文件必须翻译成越南语并经过公证，提交申请时，文件必须未过期。
申请表内容
1.组织或个人名称、地址、电话、传真、电子邮件、业务代码
2.食品安全合格证书编号、发证日期/地点
3.产品信息：名称、成分、保质期、包装规格及包装材料
4.产品製造商名称、地址
5.产品声明
标籤
1. 风险警告（如果有）
2. 营养成分：须依据越南人的推荐营养摄入量（RNI）标示
．含量低于 10% RNI 的物质不予提及。
．如果一种物质的含量为10% RNI，则应规定标示其在一份或 100 克产品中的含量。
．品中维生素、矿物质的最大含量不得超过规范，如果是越南没有规范的RNI，最大含量应符合 CODEX 或相关国际组织的规定。
3. 健康声称
．产品中的补充物质含量达到 10% RNI 或以上并有具体科学证据证明时，才可提出有关补充物质的健康声明。
．对于不含 RNI 的补充成分，只有当它们有科学证据证明或该成分的含量符合已发表的科学文献的建议时，才应在标籤上做出健康声明。
．健康声明必须清晰、一致并适合合适的使用者和剂量。
4. 补充食品的词组或国家技术法规中的标题名称
5. 经国家主管部门批准，并书面声明符合食品安全法规
6. 必须指定被禁止的用户（如果有）
7. 产品名称及标籤上的信息必须与申报文件所附的声明和材料一致
8. 产品须标示保健品
9. 当使用产生产品效果的主要成分作为产品名称时，必须在主要部分和标籤成分表上的产品名称旁边或下方写上以下信息：
．该主要成分中确定的活性成分含量
．不能确定的主要成分含量
10. 标籤上不得写药物代谢动力学。
11. 在产品效果或其他建议（如有）后必须有注意：本产品不是药物，不能替代药物的字样。该短语必须与标籤的背景颜色形成对比色，并且字母必须跨越 1.2 毫米。如果包裹的一侧小于 80 平方厘米，则字母必须至少为 0.9 毫米。
12. 使用和保存说明。
13. 负责食品的组织或个人的名称和地址。
14. 标註来源。
15. 负责商品标籤的组织或个人必须确保标籤上出现的字母、标誌、数字、图画、图像、标记等颜色清晰。特别是，表示强制性信息的颜色必须与标籤的背景颜色形成对比。
16. 表示计量单位的字母和数字的大小必须符合计量法的规定。
17. 所有强制性信息必须用越南语显示。(不得用外语书写)
18. 某些内容可以其他拉丁语种呈现，包括：
． 没有对应越南名称的药物之国际名称或学名
．附有化学、化学物质、辅料或药物成分的化学式或组成式的国际名称或学名
．成分的国际名称或学名以及成分的数量，当该名称无法翻译成越南语或越南语翻译无意义时
．参与货物製造的外国企业的名称和地址
An application can be made as a foreign business/person.
Health products are food, so manufacturers and traders who produce and sell health products in Vietnam must submit product self-announcement registration to the Food Administration (VFA).
Process
1. The applicant submits an application for registration of imported health food products to the Ministry of Health through the Internet, by post or in paper.
URL: https://vfa.gov.vn/dich-vu-cong.html(VFA)
2. Within 21 working days from the date of receipt of sufficient documents, the Ministry of Health will verify the application and issue a Certificate of Declaration for Registered Products. The time limit for document verification starts from the date specified by the online public service system (if the application is submitted online) or the stamp of the Ministry of Health (if the application is submitted by post or directly).
3. If supplementation is required, the Ministry of Health shall explain in writing and explain the legal basis, and require the applicant to supplement the application once. The supplementary application will be verified and a written reply will be given within 7 working days from the date of receipt of the supplementary application. If the applicant fails to correct the application within 90 working days from the date of the written request, the application will be invalid.
4. If the product name, place of origin or composition is changed, a separate application should be made. In case of other changes, the applicant shall notify the Ministry of Health in writing, after which the applicant shall have the right to continue producing or selling the product.
5. The Ministry of Health shall publish on its website and update in the food safety database the names and products of the registered suppliers whose product declarations have been made.
6. The applicant shall pay the fee for document verification in accordance with the fee laws.
7. The regulated product self-announcement is valid for 3 years.
8. Only the registrant can import the product. Different importers want to import the same product, they must register separately.
The registration document includes:
1. Application form.
2. Free sale certificate/export certificate/health certificate issued by the competent authority of the country of origin or exporting country, the content of which is to ensure the safety of the user or free sale in the market of the country of origin or exporting country (consular authentication).
3. The original or certified copy of the food safety data sheet (issued within 12 months before the self-declaration) issued by a designated laboratory or a laboratory in compliance with ISO17025, the data sheet must comply with international regulations (if there is no relevant Ministry of Health regulations, the supplier shall be based on the safety indicators stipulated by the Ministry of Health as the standard)
4. Scientific evidence (original or copy certified by the organization or individual) to prove the use of the product or ingredient, when scientific evidence is used to prove that the ingredients of the product are used in the product, the daily dose of the product must be at least greater than or equal to the ingredients stated in the manual 15% of usage.
5. Imported products that are health foods need to have a food safety and good manufacturing practice (GMP) certificate or an equivalent certificate.
． Manufacturers included in the list of countries that have signed a mutual recognition agreement for GMP inspections with Vietnam by the Ministry of Health.
． Manufacturers in ICH (International Committee for Harmonization of Technical Requirements for Medicinal Products for Human Use) countries or Australia that have passed GMP compliance inspections in the United States (US Food and Drug Administration – USFDA), one of the SRAs in EU countries (European Drug Administration) – EMA), Australia (Therapeutic Goods Administration – TGA), Japan (Pharmaceuticals and Medical Devices Authority – PMDA) or Canada (Health Canada) GMP certification.
． For countries that have not promulgated GMP, it is necessary to confirm in writing that the manufacturer complies with the requirements and conditions for the manufacture of nutraceutical or herbal products and traditional medicinal products, or to publish the compliance on the official website of the competent authority.
6. Regular monitoring plan.
7. Sample product label. Original label of country of origin and label in Vietnamese.
8. Finished samples.
9. Business registration certificate or investment certificate (food business license or food importer legal personality certificate certified by the unit or individual)
10. Certificate of compliance with HACCP or equivalent.
11. Registration documents must be written in Vietnamese; documents in other languages must be translated into Vietnamese and notarized, and the documents must be not expired when the application is submitted.
Contents of the application form
1. Organization or personal name, address, telephone, fax, email, business code
2. Food safety certificate number, date/place of certificate issuance
3. Product information: name, ingredients, expiration date, packaging specifications and packaging materials
4. The name and address of the manufacturer of the product
5. Product Declaration
Label
1. Risk warning (if any)
2. Nutritional content: must be declared according to the Recommended Nutrient Intake (RNI) for Vietnamese
． Substances below 10% RNI are not mentioned.
． If a substance is present at 10% RNI, provisions should be made to declare its content in one serving or 100 grams of product.
． The maximum content of vitamins and minerals in the product shall not exceed the specification. If it is an RNI that does not have a specification in Vietnam, the maximum content shall comply with the regulations of CODEX or relevant international organizations.
3. Health Claims
． A health claim for a supplement can only be made if the content of the supplement in the product is 10% RNI or more, supported by specific scientific evidence.
． For supplemental ingredients that do not contain RNI, a health claim should be made on the label only if they are supported by scientific evidence or if the ingredient is present in amounts that meet the recommendations of the published scientific literature.
． Health claims must be clear, consistent and appropriate for the appropriate user and dosage.
4. Phrase of supplementary food or title name in national technical regulations
5. Approved by the national competent authority and declared in writing that it complies with food safety regulations
6. Must specify banned users (if any)
7. The product name and information on the label must be consistent with the declarations and materials attached to the declaration document
8. Products must be labeled as health supplements
9. When using the main ingredient that produces the product’s effect as the product name, the following information must be written next to or below the product name on the main section and on the label ingredient list:
． Active ingredient content determined in the main ingredient
． Undetermined main ingredient content
10. Pharmacokinetics must not be written on the label.
11. After the product effect or other suggestions (if any), there must be a note: This product is not a drug and cannot replace the wording of a drug. The phrase must be a contrasting colour to the label’s background colour and the letters must span 1.2mm. If one side of the package is smaller than 80 cm², the letters must be at least 0.9 mm.
12. Instructions for use and storage.
13. The name and address of the organization or individual responsible for the food.
14. Indicate the source.
15. The organization or individual responsible for product labeling must ensure that the letters, logos, numbers, drawings, images, markings, etc. appearing on the labels are clearly colored. In particular, colors representing mandatory information must contrast with the background color of the label.
16. The size of the letters and numbers representing units of measurement must comply with the Law of Measurement.
17. All mandatory information must be displayed in Vietnamese. (Not written in foreign language)
18. Certain content may be presented in other Latin languages, including:
． International or scientific names of drugs that do not have a Vietnamese counterpart
． International or scientific name with chemical formula or composition formula of chemical, chemical substance, excipient or pharmaceutical ingredient
． The international or scientific name of the ingredient and the quantity of the ingredient, when the name cannot be translated into Vietnamese or Vietnamese translation is meaningless
． The name and address of the foreign business involved in the manufacture of the goods
【参考连结】
HLF-VN-45
请问在越南有哪些专业服务机构，可以协助办理保健食品产品许可证？
HLF-VN-50
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？
申请程序为何？保健食品包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？
Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do health food packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
可以以外国企业/个人身分提出申请。
保健品是食品，因此在越南生产和销售保健品的生产商、贸易商必须向食品管理局（VFA）提交产品自我公告登记。
流程
1. 申请人通过网路、邮寄或纸本向卫生部提交进口保健食品产品申报註册申请。
网页： https://vfa.gov.vn/dich-vu-cong.html（VFA）
2. 自收到充分文件之日起 21 个工作日内，卫生部将核实申请并签发註册产品申报证书。文件核验时限自收到网上公共服务系统（如果是网上提交申请）或卫生部盖章（如果是邮寄或直接提交申请）规定的日期开始计算。
3. 如果需要补充，卫生部应当书面说明并说明法律依据，要求申请人补充申请1次。自收到补充申请之日起7个工作日内予以核实并作出书面答复。申请人自提出书面请求之日起90个工作日内未补正申请的，申请将失效。
4. 产品名称、产地或成分发生变更的，应另行申请。如有其他变更，申请人应书面通知卫生部，之后有权继续生产或销售该产品。
5. 卫生部应在其网站上公佈并在食品安全数据库中更新其产品声明已註册的供应商的名称和产品。
6. 申请人应按照收费法律规定缴纳文件验证费用。
7. 法规产品自我公告的有效期为 3 年。
8. 只有登记者才可以将产品进口，不同的进口商想要进口相同的产品，必须另外提出註册。
登记文件包括：
1. 申请表。
2. 原产国或出口国主管当局签发的自由销售证明/出口证明/健康证明，内容为确保用户安全或在生产国/出口国市场上自由销售（领事认证）。
3. 指定实验室或符合 ISO17025 的实验室出具的食品安全数据表原件或经核证无误的副本(自我声明前 12 个月内出具的)，数据表必须符合国际法规（如果没有卫生部的相关法规，则由供应商依据卫生部规定的安全指标为标准）
4. 证明产品或成分用途的科学证据（组织或个人认证的原件或副本），当使用科学证据证明产品的成分用于产品用途时，产品的每日剂量必须至少大于或等于手册中所述成分使用量的 15%。
5. 进口产品为保健食品需具备食品安全和良好生产规范（GMP）合格证明或同等证明。
．卫生部列入与越南签署GMP检查互认协议的国家名单中的製造商。
．ICH（国际人用药品技术要求协调委员会）国家或澳大利亚的製造商，已通过美国（美国食品和药物管理局 – USFDA）、欧盟国家（欧洲）的 SRA 之一的 GMP 合规性检查药品管理局 – EMA）、澳大利亚（治疗用品管理局 – TGA）、日本（药品和医疗器械管理局 – PMDA）或加拿大（加拿大卫生部）GMP的证明。
．对于未颁布GMP的国家，需以书面形式确认製造商符合保健品或草药产品和传统医药产品製造的要求和条件，或在主管当局的官方网站上公佈符合性。
6. 定期监测计划。
7. 产品标籤样本。原产国的原始标籤和越南语的标籤。
8. 成品样品。
9. 商业登记证或投资证(经单位或个人认证的食品经营许可证或食品进口商法人资格证明)
10.符合HACCP或同等标准的证书。
11.註册文件必须用越南语书写；其他语言的文件必须翻译成越南语并经过公证，提交申请时，文件必须未过期。
申请表内容
1.组织或个人名称、地址、电话、传真、电子邮件、业务代码
2.食品安全合格证书编号、发证日期/地点
3.产品信息：名称、成分、保质期、包装规格及包装材料
4.产品製造商名称、地址
5.产品声明
标籤
1. 风险警告（如果有）
2. 营养成分：须依据越南人的推荐营养摄入量（RNI）标示
．含量低于 10% RNI 的物质不予提及。
．如果一种物质的含量为10% RNI，则应规定标示其在一份或 100 克产品中的含量。
．品中维生素、矿物质的最大含量不得超过规范，如果是越南没有规范的RNI，最大含量应符合 CODEX 或相关国际组织的规定。
3. 健康声称
．产品中的补充物质含量达到 10% RNI 或以上并有具体科学证据证明时，才可提出有关补充物质的健康声明。
．对于不含 RNI 的补充成分，只有当它们有科学证据证明或该成分的含量符合已发表的科学文献的建议时，才应在标籤上做出健康声明。
．健康声明必须清晰、一致并适合合适的使用者和剂量。
4. 补充食品的词组或国家技术法规中的标题名称
5. 经国家主管部门批准，并书面声明符合食品安全法规
6. 必须指定被禁止的用户（如果有）
7. 产品名称及标籤上的信息必须与申报文件所附的声明和材料一致
8. 产品须标示保健品
9. 当使用产生产品效果的主要成分作为产品名称时，必须在主要部分和标籤成分表上的产品名称旁边或下方写上以下信息：
．该主要成分中确定的活性成分含量
．不能确定的主要成分含量
10. 标籤上不得写药物代谢动力学。
11. 在产品效果或其他建议（如有）后必须有注意：本产品不是药物，不能替代药物的字样。该短语必须与标籤的背景颜色形成对比色，并且字母必须跨越 1.2 毫米。如果包裹的一侧小于 80 平方厘米，则字母必须至少为 0.9 毫米。
12. 使用和保存说明。
13. 负责食品的组织或个人的名称和地址。
14. 标註来源。
15. 负责商品标籤的组织或个人必须确保标籤上出现的字母、标誌、数字、图画、图像、标记等颜色清晰。特别是，表示强制性信息的颜色必须与标籤的背景颜色形成对比。
16. 表示计量单位的字母和数字的大小必须符合计量法的规定。
17. 所有强制性信息必须用越南语显示。(不得用外语书写)
18. 某些内容可以其他拉丁语种呈现，包括：
． 没有对应越南名称的药物之国际名称或学名
．附有化学、化学物质、辅料或药物成分的化学式或组成式的国际名称或学名
．成分的国际名称或学名以及成分的数量，当该名称无法翻译成越南语或越南语翻译无意义时
．参与货物製造的外国企业的名称和地址
An application can be made as a foreign business/person.
Health products are food, so manufacturers and traders who produce and sell health products in Vietnam must submit product self-announcement registration to the Food Administration (VFA).
Process
1. The applicant submits an application for registration of imported health food products to the Ministry of Health through the Internet, by post or in paper.
URL: https://vfa.gov.vn/dich-vu-cong.html(VFA)
2. Within 21 working days from the date of receipt of sufficient documents, the Ministry of Health will verify the application and issue a Certificate of Declaration for Registered Products. The time limit for document verification starts from the date specified by the online public service system (if the application is submitted online) or the stamp of the Ministry of Health (if the application is submitted by post or directly).
3. If supplementation is required, the Ministry of Health shall explain in writing and explain the legal basis, and require the applicant to supplement the application once. The supplementary application will be verified and a written reply will be given within 7 working days from the date of receipt of the supplementary application. If the applicant fails to correct the application within 90 working days from the date of the written request, the application will be invalid.
4. If the product name, place of origin or composition is changed, a separate application should be made. In case of other changes, the applicant shall notify the Ministry of Health in writing, after which the applicant shall have the right to continue producing or selling the product.
5. The Ministry of Health shall publish on its website and update in the food safety database the names and products of the registered suppliers whose product declarations have been made.
6. The applicant shall pay the fee for document verification in accordance with the fee laws.
7. The regulated product self-announcement is valid for 3 years.
8. Only the registrant can import the product. Different importers want to import the same product, they must register separately.
The registration document includes:
1. Application form.
2. Free sale certificate/export certificate/health certificate issued by the competent authority of the country of origin or exporting country, the content of which is to ensure the safety of the user or free sale in the market of the country of origin or exporting country (consular authentication).
3. The original or certified copy of the food safety data sheet (issued within 12 months before the self-declaration) issued by a designated laboratory or a laboratory in compliance with ISO17025, the data sheet must comply with international regulations (if there is no relevant Ministry of Health regulations, the supplier shall be based on the safety indicators stipulated by the Ministry of Health as the standard)
4. Scientific evidence (original or copy certified by the organization or individual) to prove the use of the product or ingredient, when scientific evidence is used to prove that the ingredients of the product are used in the product, the daily dose of the product must be at least greater than or equal to the ingredients stated in the manual 15% of usage.
5. Imported products that are health foods need to have a food safety and good manufacturing practice (GMP) certificate or an equivalent certificate.
． Manufacturers included in the list of countries that have signed a mutual recognition agreement for GMP inspections with Vietnam by the Ministry of Health.
． Manufacturers in ICH (International Committee for Harmonization of Technical Requirements for Medicinal Products for Human Use) countries or Australia that have passed GMP compliance inspections in the United States (US Food and Drug Administration – USFDA), one of the SRAs in EU countries (European Drug Administration) – EMA), Australia (Therapeutic Goods Administration – TGA), Japan (Pharmaceuticals and Medical Devices Authority – PMDA) or Canada (Health Canada) GMP certification.
． For countries that have not promulgated GMP, it is necessary to confirm in writing that the manufacturer complies with the requirements and conditions for the manufacture of nutraceutical or herbal products and traditional medicinal products, or to publish the compliance on the official website of the competent authority.
6. Regular monitoring plan.
7. Sample product label. Original label of country of origin and label in Vietnamese.
8. Finished samples.
9. Business registration certificate or investment certificate (food business license or food importer legal personality certificate certified by the unit or individual)
10. Certificate of compliance with HACCP or equivalent.
11. Registration documents must be written in Vietnamese; documents in other languages must be translated into Vietnamese and notarized, and the documents must be not expired when the application is submitted.
Contents of the application form
1. Organization or personal name, address, telephone, fax, email, business code
2. Food safety certificate number, date/place of certificate issuance
3. Product information: name, ingredients, expiration date, packaging specifications and packaging materials
4. The name and address of the manufacturer of the product
5. Product Declaration
Label
1. Risk warning (if any)
2. Nutritional content: must be declared according to the Recommended Nutrient Intake (RNI) for Vietnamese
． Substances below 10% RNI are not mentioned.
． If a substance is present at 10% RNI, provisions should be made to declare its content in one serving or 100 grams of product.
． The maximum content of vitamins and minerals in the product shall not exceed the specification. If it is an RNI that does not have a specification in Vietnam, the maximum content shall comply with the regulations of CODEX or relevant international organizations.
3. Health Claims
． A health claim for a supplement can only be made if the content of the supplement in the product is 10% RNI or more, supported by specific scientific evidence.
． For supplemental ingredients that do not contain RNI, a health claim should be made on the label only if they are supported by scientific evidence or if the ingredient is present in amounts that meet the recommendations of the published scientific literature.
． Health claims must be clear, consistent and appropriate for the appropriate user and dosage.
4. Phrase of supplementary food or title name in national technical regulations
5. Approved by the national competent authority and declared in writing that it complies with food safety regulations
6. Must specify banned users (if any)
7. The product name and information on the label must be consistent with the declarations and materials attached to the declaration document
8. Products must be labeled as health supplements
9. When using the main ingredient that produces the product’s effect as the product name, the following information must be written next to or below the product name on the main section and on the label ingredient list:
． Active ingredient content determined in the main ingredient
． Undetermined main ingredient content
10. Pharmacokinetics must not be written on the label.
11. After the product effect or other suggestions (if any), there must be a note: This product is not a drug and cannot replace the wording of a drug. The phrase must be a contrasting colour to the label’s background colour and the letters must span 1.2mm. If one side of the package is smaller than 80 cm², the letters must be at least 0.9 mm.
12. Instructions for use and storage.
13. The name and address of the organization or individual responsible for the food.
14. Indicate the source.
15. The organization or individual responsible for product labeling must ensure that the letters, logos, numbers, drawings, images, markings, etc. appearing on the labels are clearly colored. In particular, colors representing mandatory information must contrast with the background color of the label.
16. The size of the letters and numbers representing units of measurement must comply with the Law of Measurement.
17. All mandatory information must be displayed in Vietnamese. (Not written in foreign language)
18. Certain content may be presented in other Latin languages, including:
． International or scientific names of drugs that do not have a Vietnamese counterpart
． International or scientific name with chemical formula or composition formula of chemical, chemical substance, excipient or pharmaceutical ingredient
． The international or scientific name of the ingredient and the quantity of the ingredient, when the name cannot be translated into Vietnamese or Vietnamese translation is meaningless
． The name and address of the foreign business involved in the manufacture of the goods
【参考连结】
HLF-VN-55
请问在越南有哪些专业服务机构，可以协助以外国公司名义办理保健食品产品许可证？
HLF-VN-60
经过核准登记的保健食品，进口到越南要检附什麽文件？经过什麽手续？
在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？
What documents are required when importing approved health food into Vietnam? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
海关流程
1.所有进口到越南的货物都必须申报并徵税，除非货物符合免税或税收保护的条件。贸易商可通过国家单一窗口或越南自动清关系统 (VNACCS) 提交所需信息、电子报关单。
2.进口商需自到货之日起30日内通过VNACCS系统提交完整无误的电子报关单、运输单证信息（如提单等）。
3. 申报报关提交文件
．已签署的报关单（原件）
．商业登记证複印件
．授权书原件或公证副本
．原产国的自由销售证明
．商业发票（複印件）
．销售合同（複印件）
．定期提单或空运提单
．货物清单（如有）
．原产地证书（C/O）
．保健品的产品自我公告证明，以取得者可以免检（有食品安全警示的除外）
．装箱单
．价值声明（如有）
．收据（如有）
．原产地证书（如有）
．检验官为每批货物签发的符合食品进口要求的证明书
．食品证明书
．卫生和安全性之文件
4. 按规定缴纳税费，接收清关信息。
5.报关单内容
．报关登记海关分部
．提交日期和时间
．註册日期和时间
．进口口岸海关分局
．申报附件数量
．出口商、类型
．商业发票
．许可证号
．合同
．进口商
．提单（编号/日期）
．装货港、卸货港
．受託人/委託人
．运输工具
．出口国
．报关员
．到货日期
．交货条件
．付款方式、支付货币、税率
．商品说明、产品代码、项目、数量、价值等
5.仓储
．如果进口商不打算立即将货物投入越南流通，可以根据海关仓库储存制度进口到越南。商品入库时实行税收保护，商品投入流通时才徵收税款。
．贸易商在入库时需要提交保税仓储制度下的进口报关单，在货物进入流通时需要提交正规的进口报关单。
．仓库有多种类型（保税仓库、暂缓税仓库），带入仓库的货物必须得到越南海关总署或财政部的批准。
无销售通知，但必须在广告前完成认证登记，保健品广告内容的登记，除符合广告法的规定外，还必须符合下列规定：
1. 必须有本食品非药品，不能代替药品的警告，字迹必须清晰，颜色与背景颜色形成鲜明对比。
2. 时长小于15秒的电视、报纸上的广告，不要求写“本食品非药，不能代替药”，但必须在广告中出现警告。
广告内容认证登记申请文件包括：
1. 申请网页： https://nghidinh15.vfa.gov.vn/（VFA）
2. 产品公告登记的书面回执和经主管部门认证的产品公告。
3. 产品标籤样本。
4. 报刊上刊登广告，必须有广告文字，并将广告内容记录在音像或音像盘上；以其他方式投放广告的，必须有广告策划图（内容样本）。
5. 于产品公告中所述产品用途和特点以外的广告内容，必须有科学文件证明。
6. 申请广告内容认证的文件必须是越南语；如果有外文文件，必须翻译成越南文并经过公证。
程序
1. 拥有广告产品的组织和个人应当向出具产品公告登记回执的机构发送广告内容证明登记。
2. 10 个工作日内进行审议并返回结果。
3. 对组织或者个人的广告内容有异议或者要求修改、补充的，受理机构应当书面说明理由和法律依据，只能一次。
4. 自收到书面修改补充申请之日起90个工作日后，组织或者个人不修改、补充档案的，该档案不再有效。
5. 接收广告内容认证登记的机构负责在网站、其电子信息（网站）和食品安全数据库上公佈获得食品广告内容证书的组织和个人的名称和产品。
6. 註册广告内容认证的组织和个人有责任在申请受理机构缴纳申请费。
7. 拥有广告产品的组织和个人；发布广告的组织和个人只能对已获得广告内容证书的产品进行广告宣传，并且只能按照已获得广告内容证书的内容进行广告宣传。
After obtaining the receipt number of imported cosmetics, you can import cosmetics to Vietnam according to customs procedures.
customs process
1. All goods imported into Vietnam must be declared and taxed, unless the goods are eligible for tax exemption or tax protection. Traders can submit the required information, electronic customs declarations through the National Single Window or the Vietnam Automated Customs Clearance System (VNACCS).
2. Importers are required to submit complete and correct electronic customs declarations and transport documents (such as bills of lading, etc.) through the VNACCS system within 30 days from the date of arrival.
3. Declaration and declaration submission
．Signed declaration form (original)
．Copy of business registration certificate
．Original power of attorney or notarized copy
．Certificate of free sale in the country of origin
．Commercial Invoice (photocopy)
．Sales contract (copy)
．Periodic Bill of Lading or Air Waybill
．List of goods (if any)
．Certificate of Origin (C/O)
．Product self-announcement certificate of health care products, so that the acquirer can be exempted from inspection (except for those with food safety warnings)
．Packing List
．Value statement (if any)
．Receipts (if any)
．Certificate of Origin (if any)
．Certificate of compliance with food import requirements issued by an inspector for each shipment
．Food Certificate
．Health and Safety Documentation
4. Pay taxes and fees and receive customs clearance information as required.
5. Contents of customs declaration form
．Customs Registration and Customs Division
．Submission date and time
．Registration date and time
．Import port customs branch
．Number of declaration attachments
．Exporter, Type
．Commercial invoice
．Permit number
．Contract
．Importers
．Bill of Lading (No/Date)
．Port of loading, port of discharge
．Trustee / Settlor
．Yransportation
．Export country
．Customs declarer
．Arrival date
．Delivery terms
．Payment method, payment currency, tax rate
．Commodity description, product code, item, quantity, value, etc.
5. Warehousing
．If the importer does not plan to put the goods into Vietnam for circulation immediately, they can import to Vietnam according to the customs warehouse storage system. Tax protection is implemented when commodities are put into storage, and taxes are collected when commodities are put into circulation.
．Traders need to submit the import declaration form under the bonded storage system when entering the warehouse, and they need to submit the formal import declaration form when the goods enter the circulation.
．There are various types of warehouses (bonded warehouses, deferred tax warehouses), and the goods brought into the warehouses must be approved by the Vietnam Customs Department or the Ministry of Finance.
There is no sales notification, but the certification registration must be completed before the advertisement. The registration of the advertisement content of health products must meet the following requirements in addition to the provisions of the Advertising Law:
1. There must be a warning that this food is not a drug and cannot replace a drug, the handwriting must be clear, and the color must be in sharp contrast with the background color.
2. Advertisements on TV and newspapers with a duration of less than 15 seconds are not required to write “This food is not a medicine and cannot be used as a substitute for medicine”, but a warning must appear in the advertisement.
The application documents for advertisement content certification registration include:
1. Application webpage: https://nghidinh15.vfa.gov.vn/ (VFA)
2. Written receipt of product announcement registration and product announcement certified by the competent authority.
3. Sample product label.
4. Advertisements published in newspapers and periodicals must contain advertisement text and record the advertisement content on audio-visual or audio-visual discs; if advertisements are placed in other ways, there must be advertisement planning diagrams (content samples).
5. Advertising content other than the product use and characteristics stated in the product announcement must be proved by scientific documents.
6. The documents applying for the certification of advertising content must be in Vietnamese; if there are documents in foreign languages, they must be translated into Vietnamese and notarized.
Program
1. Organizations and individuals who own advertised products should send the advertisement content certificate to the agency that issued the product announcement registration receipt.
2. Review and return results within 10 working days.
3. If there is any objection to the content of the advertisement of the organization or individual, or it is required to be revised or supplemented, the acceptance agency shall explain the reasons and legal basis in writing, only once.
4. After 90 working days from the date of receipt of the written amendment and supplementary application, if the organization or individual does not revise or supplement the file, the file will no longer be valid.
5. The agency receiving the advertising content certification registration is responsible for publishing the names and products of the organizations and individuals that have obtained the food advertising content certification on the website, its electronic information (website) and food safety database.
6. Organizations and individuals that register for advertising content certification are responsible for paying the application fee at the application acceptance agency.
7. Organizations and individuals who own advertising products; organizations and individuals that publish advertisements can only advertise products that have obtained advertising content certificates, and can only advertise according to the content that has obtained advertising content certificates.
【参考连结】
https://dknsd.customs.gov.vn/Pages/dn.aspx
https://nghidinh15.vfa.gov.vn/
HLF-VN-70
越南保健食品审核机构，需要附上的实验室检验资料有哪些? 网页？
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
1. 指定实验室或符合 ISO17025 的实验室出具的食品安全数据表原件或经核证无误的副本(自我声明前 12 个月内出具的)，数据表必须符合国际法规（如果没有卫生部的相关法规，则由供应商依据卫生部规定的安全指标为标准）
．製造商/进口商/供应商/经销商信息：名称、地址、电话、网址等
．危害识别：急性毒性、皮肤腐蚀、眼睛刺激、呼吸或皮肤过敏、生殖细胞致突变性、致癌性、生殖毒性等
．成分/成分信息
．急救措施
．消防措施
．设备和应急程序
．处理和储存
．接触控制/个人防护
．个人防护装备 (PPE)
．理化性质
．稳定性和反应
．毒理学资料
．生态信息
．处置注意事项等
2.食品安全和良好生产规范（GMP）合格证明或同等证明。
．建立和维护质量管理体系，以控制生产和分销过程，确保该企业生产的所有产品均符合公佈的标准并可供人类安全食用，直至到期日。
．足够数量的人员，具备与其分配的工作岗位相适应的专业资格，并接受过基本的GMP知识、食品安全和相关专业知识的培训。生产负责人和质量控制负责人必须是该机构的全职员工，并且相互独立。机构专业负责人必须具有医学、药学、营养学、食品安全、食品技术等专业之一的大学本科以上学历，并具有3年以上相关专业领域的工作经验。
．车间、设备及附属设施系统按照使用目的设计、建造和安装，单向原则，易于清洁，防止和最大程度减少错误风险，避免汙垢堆积、汙染等对产品产生不利影响的因素，并保持日常清洁活动。
．实施和维护有关生产、质量控制、流通和分销的完整记录和文件，以检索每个产品批次的历史记录并记录执行的所有其他活动。
．所有生产操作必须遵循流程和说明。在生产过程中採取检查和监督措施，防止和避免混淆、汙染和交叉汙染的风险。执行操作后立即记录结果或在记录中完成生产阶段后立即记录结果。
．设有质量控制部门，以确保产品在适当的条件和工艺下製造并符合既定标准；已进行必要的测试；产品质量不合格不准销售；必须监测产品的稳定性。
．检测或委託生产的受委託方必须有足够的厂房、设备和人员，以满足转让方的要求，并符合主管管理机构对检测或生产保健食品条件的规定。
．有规定投诉处理、产品召回和自检流程；遵循程序并记录并保留这些活动的充分记录等。
3.符合HACCP或同等标准的证书。
．危害分析：从原料採收处理开始，经由加工、包装、流通乃至最终产品提供消费者为止，进行一科学化及系统化之评估分析整个过程，以了解各种潜在性危害发生之可能性及其危害程度。
．重要管制点：对可能造成显着危害之製程中某一点、步骤或程序，以有效监控方法(措施与条件)以预防、去除或降低食品危害至最低可以接受之程度。
．建立管制界限
．执行管制监测
．建立矫正措施
．建立记录系统
．实施Codex HACCP (危害分析及重要管制点)食品卫生系统等
1. The original or certified copy of the food safety data sheet (issued within 12 months prior to the self-declaration) issued by a designated laboratory or ISO17025-compliant laboratory, the data sheet must comply with international regulations (if there is no relevant Ministry of Health regulations, the supplier shall be based on the safety indicators stipulated by the Ministry of Health as the standard)
．Manufacturer/Importer/Supplier/Distributor Information: Name, Address, Phone, Website, etc.
．Hazard identification: acute toxicity, skin corrosion, eye irritation, respiratory or skin allergy, germ cell mutagenicity, carcinogenicity, reproductive toxicity, etc.
．Ingredients/Ingredient Information
．First Aid
．Fire-fighting measures
．Equipment and Emergency Procedures
．Handling and storage
．Exposure Controls/Personal Protection
．Personal Protective Equipment (PPE)
．Physical and chemical properties
．Stability and Responsiveness
．Toxicological information
．Ecology Information
．Handling precautions, etc.
2. Food safety and Good Manufacturing Practice (GMP) certificate of conformity or equivalent.
．Establish and maintain a quality management system to control the production and distribution process to ensure that all products produced by this business meet published standards and are safe for human consumption until the expiration date.
．A sufficient number of personnel with professional qualifications appropriate to their assigned jobs and trained in basic GMP knowledge, food safety and related professional knowledge. The Head of Production and Head of Quality Control must be full-time employees of the facility and be independent of each other. The person in charge of the institution must have a bachelor’s degree or above in one of the majors in medicine, pharmacy, nutrition, food safety, food technology, etc., and have more than 3 years of work experience in related professional fields.
．Workshops, equipment and ancillary facilities systems are designed, constructed and installed in accordance with the purpose of use, one-way principle, easy to clean, prevent and minimize the risk of errors, avoid factors such as dirt accumulation and contamination that adversely affect the product, and maintain daily cleaning activities .
．Implement and maintain complete records and documentation regarding production, quality control, circulation and distribution to retrieve the history of each product batch and record all other activities performed.
．All production operations must follow processes and instructions. Inspection and supervision measures are taken during the production process to prevent and avoid the risk of mix-ups, contamination and cross-contamination. The result is recorded immediately after the action is performed or after the production stage is completed in the record.
．There is a quality control department to ensure that products are manufactured under proper conditions and processes and meet established standards; necessary tests have been carried out; products are not of acceptable quality for sale; product stability must be monitored.
．The entrusted party for testing or entrusted production must have sufficient plant, equipment and personnel to meet the requirements of the transferor and comply with the regulations of the competent management agency on the conditions for testing or producing health food.
．Procedures for complaint handling, product recalls and self-inspection are in place; procedures are followed and adequate records of these activities are recorded and maintained, etc.
3. Certificate of compliance with HACCP or equivalent.
．Hazard analysis: From raw material harvesting and processing, through processing, packaging, distribution and final product delivery to consumers, a scientific and systematic evaluation and analysis of the entire process is carried out to understand the possibility of various potential hazards and their hazards degree.
．Important control point: For a point, step or procedure in the process that may cause significant harm, effective monitoring methods (measures and conditions) are used to prevent, remove or reduce food hazards to a minimum acceptable level.
．Establish regulatory boundaries
．Executive Regulatory Monitoring
．Establish corrective measures
．Establish a system of record
．Implement Codex HACCP (Hazard Analysis and Critical Control Points) food hygiene system, etc.
【参考连结】
https://vfa.gov.vn/thu-tuc-hanh-chinh.html
HLF-VN-75
HLF-VN-77
请问在越南有哪些保健食品检验机构可以提供保健食品检验服务？网页？
HLF-VN-80
外国子公司进口保健食品后，如果委託越南的经销商销售，经销商需要保健食品营业许可证吗？
假如保健食品有品质瑕疵的话，外国子公司和经销商各自的责任为何？是连带责任吗？还是可以规范由外国子公司负责？
After a foreign subsidiary imports health food and entrusts a distributor in Vietnam to sell it, does the distributor need a health food business license? What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
无须申请营业特许证。
当发现不安全产品时，生产、销售保健品的个人或企业应召回不安全产品并向越南食品管理局（VFA）提交报告，生产、销售者应当处理该产品，并承担全部召回和处理费用。
在某些紧急情况下，国家主管部门可以直接召回和处置不安全食品，并要求生产、销售者报销召回和处置费用。此外，根据消费者权益保护法，一旦发现有缺陷的产品，製造商/贸易商必须立即採取一切必要措施，停止在市场上供应此类产品。
这包括召回有缺陷的产品，并在至少连续 5 期日报或连续 5 天在产品流通地区的广播或电视上发布有关缺陷产品的信息。此外，如果有缺陷的产品对消费者的生命或健康造成严重损害，贸易商/製造商必须向消费者支付赔偿。
No business license is required.
When unsafe products are found, individuals or enterprises that produce and sell health supplements should recall the unsafe products and submit a report to the Vietnam Food Administration (VFA).
In some emergency situations, the national competent authority can directly recall and dispose of unsafe food, and require the manufacturer and seller to reimburse the recall and disposal costs. Furthermore, in accordance with consumer protection law, as soon as a defective product is discovered, the manufacturer/trader must immediately take all necessary measures to stop supplying such product on the market. This includes recalling defective products and publishing information about defective products in at least 5 consecutive daily newspapers or 5 consecutive days on radio or television in the area in which the product is circulated. In addition, the trader/manufacturer must pay compensation to the consumer if the defective product causes serious damage to the consumer’s life or health.
【参考连结】
HLF-VN-85
请问在越南有哪些专精于保健食品销售与消费权益相关法律服务的业者？
Email：han4ww@evershinecpa.com
或
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